A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Recruiting now · Phase 2/Phase 3

Conditions studied: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia

In brief

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Key facts

Study ID

NCT06767683

Run by

Alkermes, Inc.

People needed

256

Starts

2025-01-27

Expected to finish

2028-06-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
• Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

You may not qualify if…

• Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
• Is currently pregnant, breastfeeding, or planning to become pregnant during the study
• Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Where it is running

• Alkermes Investigational Site — Cullman, Alabama, United States (enrolling)
• Alkermes Investigator Site — Phoenix, Arizona, United States (enrolling)
• Alkermes Investigational Site — Little Rock, Arkansas, United States (enrolling)
• Alkermes Investigational Site — Los Angeles, California, United States (enrolling)
• Alkermes Investigator Site — San Francisco, California, United States (enrolling)
• Alkermes Investigational Site — Stanford, California, United States (enrolling)
• Alkermes Investigational Site — Boulder, Colorado, United States (enrolling)
• Alkermes Investigational Site — Colorado Springs, Colorado, United States (enrolling)
• Alkermes Investigational Site — Brandon, Florida, United States (enrolling)
• Alkermes Investigational Site — Miami, Florida, United States (enrolling)
• Alkermes Investigational Site — Winter Park, Florida, United States (enrolling)
• Alkermes Investigational Site — Atlanta, Georgia, United States (enrolling)
• Alkermes Investigational Site — Macon, Georgia, United States (enrolling)
• Alkermes Investigational Site — Stockbridge, Georgia, United States (enrolling)
• Alkermes Investigational Site — Peoria, Illinois, United States (enrolling)
• Alkermes Investigational Site — Kansas City, Kansas, United States (enrolling)
• Alkermes Investigational Site — Lansing, Michigan, United States (enrolling)
• Alkermes Investigational Site — Sterling Heights, Michigan, United States (enrolling)
• Alkermes Investigational Site — Lincoln, Nebraska, United States (enrolling)
• Alkermes Investigational Site — Middletown, New Jersey, United States (enrolling)
• Alkermes Investigational Site — Denver, North Carolina, United States (enrolling)
• Alkermes Investigational Site — Huntersville, North Carolina, United States (enrolling)
• Alkermes Investigational Site — Canton, Ohio, United States (enrolling)
• Alkermes Investigational Site — Cincinnati, Ohio, United States (enrolling)
• Alkermes Investigational Site — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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